Yes, we recommend you document an Internal Audit Procedure - this addresses two of the ISO 9001 clauses - Performance Evaluation and Improvement. It will greatly help you with the process of auditing and internal audit management.
Control of Internal Audits Procedure
The purpose of this procedure is to define your organization's process for undertaking QMS audits, process audits, and supplier and legislation audits in order to assess the effectiveness of the application of the quality management system and its compliance to ISO 9001:2015.
This procedure also defines the responsibilities for planning and conducting audits, reporting results and retaining associated records.
Looking For Help with Your Internal Audit Procedure?
Our Control of Internal Audits Procedure includes:
- Procedure - view sample
- Internal Audit Porcess Flowchart
- Audit Report
- Audit Feedback Form - view sample
- Internal Audit Process Map - view sample
Save Time and Money — Proven to Work
Before you invest all the hours reinventing the wheel, before you spend countless dollars outsourcing the task — try our Internal Audit Checklist.
A Gap Analysis
Iso 9001 Audit Checklist Template
The gap analysis will likely be your first ISO 9001:2015 internal audit. The gap analysis checklist highlights the new requirements contained in ISO 9001:2015 but it not intended to cover all of the requirements from ISO 9001:2015 comprehensively.
The unique knowledge obtained about the status your existing quality management system will be a key driver of the subsequent implementation approach. Armed with this knowledge, it allows you to establish accurate budgets, time-lines and expectations which are proportional to the state of your current management system when directly compared to the requirements of the standards.
Your organization may already have in place an ISO 9001:2008 compliant quality management system or you might be running an uncertified system. If this is the case, you will want to determine how closely your system conforms to the requirements ISO 9001:2015.
The results of a gap analysis exercise will help to determine the differences, or gaps, between your existing management system and the new requirements. Not only will the analysis template help you to identify the gaps, it will also allow you to recommend how those gaps should be filled.
The gap analysis output also provides a valuable baseline for the implementation process as a whole and for measuring progress. Try to understand each business process in the context of each of the requirements by comparing different activities and processes with what the standard requires. At the end of this activity you will have a list of activities and processes that comply and ones that do not comply. The latter list now becomes the target of your implementation plan.
Don't Try to Manage It All Alone!
Take a look at our Gap Analysis Checklists.
Preparing the Audit Report
A good summary report is the output which is the value of the audit. It deserves an appropriate amount of attention and effort. As you moved through the audit, you should have noted the issues and improvements you saw. These should have been marked clearly so you are now able to quickly review and capture them as you write the report.
These findings and conclusions should be formally documented as part of the summary report. Too often, the audit report only recites back facts and data the managers already know. The value is in identifying issues and opportunities they do not know! This summary should be reviewed first with the lead auditor, then the Process Owner and Management Team. Make final revisions and file the audit report and all supporting audit materials and notes.
Gather the whole audit package together, in an organized manner. The rest of the work instructions, flowcharts, notes and relevant papers should be gathered into the audit package as supporting records. Mac os 8.6. All findings should also be documented on your corrective action forms. The audit summary and the corrective action forms should be attached to the audit package, which now becomes the audit record. Only the summary report and corrective actions need be given to the process owner.
Elementary Audit Questions
These basic audit questions will help guide the audit in the right direction since the answers they provide often unlock the doors to information the auditor requires in order to accurately assess the particulars of a process.
Consider these common audit questions:
- What are your responsibilities?
- How do you know how to carry them out?
- What kind of training is given to new employees?
- How is the effectiveness of training evaluated?
- Are training records maintained?
- What are the objectives of your processes?
- What is the quality policy and where is it found?
- Which documents do you use and are they correct?
- What outputs does your process create?
- How are your records maintained?
- How do you ensure that products meet the stated requirements?
- Is customer satisfaction data analyzed?
- How do you ensure that products meet the stated requirements?
- What happens when changes are made to product requirements?
- What are the responsibilities/authorities for dealing with non-conformances
- Are there trends in non-conforming products and what's being done about it?
- Is the non-conformance procedure linked to the corrective action process?
- Are employees made aware of the quality policy and objectives?
- Are policies and objectives available and relevant?
- How are quality objectives determined?
- Is there a clear link between the policies and objectives?
- How is progress towards objectives measured and communicated?
- Has the number of customer complaints changed over time?
- What tools are used to identify the causes of complaints?
- How are improvement efforts and successes communicated to employees?
Getting the Most from the Audit Schedule
The audit schedule is divided up to reflect each section of ISO 9001 You should determine which of these sections are of greatest relevance to your business; in other words, which processes, should there be problems, will affect your customers the most. These are the processes that your company must make certain remain stable and consistent. You might wish to schedule these key processes for additional audits, perhaps two or even three times per year.
The audit schedule provides the following benefits:
- Provides a visual plan of the audit programme
- Demonstrates coverage of the whole standard
- Provide current status of the audit programme
- Promotes awareness
Other types of Audit
- Certification Audit (also know as an ISO Compliance Audit)
- Surveillance Audit (this is also an ISO Audit)
Is a Certified Auditor 'Required' To Do An ISO Audit or Can the Company do the ISO Audit Themselves?
Ck2 eu4 to vic2. You do not need a 'Certified Auditor' to undertake internal quality audits of your management system and its processes.
Certified Auditors normally work for external, third-party accreditation bodies such as DNV, UKAS, LRQA, who will perform the Certification Audit, that is, assess your organization's management system against the requirements of ISO 9001 and provide your certificate of compliance. They will also conduct Surveillance Audits to ensure that your certification is maintained. They would not be involved in day-to-day internal auditing operations.
Internal Auditors can be people from within your organization who posses the necessary competence and impartiality to undertake internal audits in order to ensure effective operation of your organization's processes. The Internal Auditors often report to the Quality Manager.
Internal Auditing & Gap Analysis
